Vyndaqel
Pronunciation: VIN-duh-kel
Generic name: tafamidis meglumine
Dosage form: oral capsule
Drug class: Transthyretin stabilizers
What is Vyndaqel?
Vyndaqel (tafamidis meglumine) is a transthyretin stabilizer that may be given to reduce death or hospitalization caused by heart problems in adults with cardiomyopathy (damage of the heart muscle) caused by wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).
Vyndaqel (tafamidis meglumine) works by attaching to the transthyretin protein, which is an important protein primarily produced by the liver, but also in small amounts by the outer lining of the brain and retina. TTR carries the thyroid hormone thyroxine and retinol (vitamin A) throughout the body. Vyndaqel stabilizes TTR, helping it to stay together, and slowing the breakdown and build-up of dangerous deposits, which can help slow the progression of ATTR-CM.
Vyndaqel was FDA-approved on May 3, 2019.
The difference between Vyndaqel and Vyndamax is their form of tafamidis. Vyndaqel has the micronized meglumine salt, while Vyndamax has the free acid form. Vyndamax is designed for convenience, with one capsule taken daily, while Vyndaqel requires four capsules daily. No generic versions are available for either.
Vyndaqel side effects
The rate of side effects reported during clinical trials of Vyndaqel was similar to placebo (an inactive treatment). Diarrhea has been reported as a possible side effect during post-approval use.
- No additional lab testing or monitoring is required in people taking Vyndaqel.
- As with any medicine, hypersensitivity reactions are possible. Get emergency medical help if you have signs of an allergic reaction, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Warnings
There are no warnings or contraindications for Vyndaqel.
Before taking
Before taking Vyndaqel, tell your healthcare provider about all your medical conditions, including if you:
- have liver problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
Vyndaqel may harm your unborn baby. You may need to take a pregnancy test before starting treatment and use effective contraception throughout treatment. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Vyndaqel. You may also report your pregnancy by calling the Pfizer reporting line at 1-800-438-1985.
Breastfeeding
It is not known if Vyndaqel passes into your breast milk. You should not breastfeed during treatment with Vyndaqel. Talk to your healthcare provider about the best way to feed your baby during treatment.
How do I take Vyndaqel?
Take Vyndaqel exactly as your healthcare provider tells you to take it.
Vyndaqel is usually taken once a day. Try to take it at around the same time each day.
- The usual dosage is 80 mg (4 capsules of 20 mg) once a day.
- You cannot substitute Vyndaqel for Vyndamax on a mg-to-mg basis.
Swallow the capsules whole. Do not crush or cut.
Related/similar drugs
Vyndamax, Amvuttra, Onpattro, Tegsedi, Wainua, tafamidis, eplontersen, patisiran
What happens if I miss a dose?
If you miss a dose of Vyndaqel, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regularly scheduled time. Do not take 2 doses at the same time.
What other drugs will affect Vyndaqel?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect the way Vyndaqel works, and Vyndaqel may affect how some medicines work. Especially tell your healthcare provider if you take:
- medications that are BCRP substrates such as methotrexate, rosuvastatin, or imatinib. Monitor for signs of BCRP substrate-related toxicities and modify the dosage of the substrate if appropriate.
Know the medicines you take. Keep a list of all your medicines. Show them to your healthcare provider or pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.
Storage
Store Vyndaqel at room temperature between 68°F to 77°F (20°C to 25°C).
Keep out of the reach of children.
Vyndaqel ingredients
Active ingredient: tafamidis meglumine 20 mg
Inactive ingredients: ammonium hydroxide 28%, brilliant blue FCF, carmine, gelatin, glycerin, iron oxide (yellow), polyethylene glycol 400, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, sorbitan monooleate, sorbitol, and titanium dioxide
Manufacturer
Pfizer Inc.
Popular FAQ
What’s the difference between Vyndaqel and Vyndamax?
The difference between Vyndaqel and Vyndamax lies in the form of tafamidis, their active ingredient, that they contain.
Vyndaqel contains the micronized meglumine salt of tafamidis, while Vyndamax contains the free acid form of tafamidis.
Vyndamax was developed for patient convenience and this formulation allows patients to take just one capsule once per day. Patients taking Vyndaqel, on the other hand, need to take four capsules once a day. Continue reading
How long does it take for Vyndaqel to start working?
It takes at least 6 months for Vyndaqel to start working and it may take up to 18 months for the full effects to be seen, but these persist for at least 30 months. There was significantly less decline in functional capacity (as measured by a 6-minute walk test [6MWT]) and health status (as measured by the Kansas City Cardiomyopathy Questionnaire-Overall Summary [KCCQ-OS]) with Vyndaqel at 6 months than placebo. It may take at least 18 months before Vyndaqel makes a difference in all cause mortality compared to placebo, but this difference persists and trials have reported a survival rate of 71% in those taking Vyndaqel compared to 57% taking placebo. Those receiving Vyndaqel had 32% less hospitalizations due to heart problems, also statistically significant. Continue reading
How does Vyndaqel work for ATTR-CM?
Vyndaqel works in ATTR-CM (cardiomyopathy of transthyretin-mediated amyloidosis) by binding to and stabilizing the transthyretin (TTR) transport protein. This slows down the production of amyloid deposits in the heart that lead to ATTR-CM.
Continue readingHow long does it take Vyndamax to work?
Vyndamax, when compared to a placebo, was shown to improve the survival rates (71% vs. 57%, respectively) for patients with wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) over a 30-month long clinical study. Quality-of-life measurements improved as early as 6 months. Continue reading
References
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